Issue
While MiraLax (polyethylene glycol 3350) is typically intended for use in patients 17 years of age and older, it has apparently been prescribed “off-label” for many years to children for constipation relief.
What’s worse is that MiraLax is typically prescribed for a maximum of seven days to adults, but some children were taking it for much longer periods of time in order to treat chronic constipation.
Thousands of parents whose children were prescribed MiraLax observed deeply troubling neuropsychiatric problems in their children after using MiraLax such as:
- Depression
- Anger
- Anxiety
- Paranoia
- Mood swings
In fact, a “Citizen Petition to Investigate Polyethylene Glycol 3350 Product Safety for Use with Pediatric Patients” was filed back in 2012 urging the FDA to add a “black box” warning to its label pertaining to neuropsychiatric side effects in children. They also requested information concerning all clinical trials and studies done on polyethylene glycol (PEG) 3350, and demanded that the FDA conduct additional studies on its effects in children.
FDA’s Response
| 2006 | The FDA deferred submission of studies concerning the effects of MiraLax on the pediatric population (those 16 years of age or younger) until October 2016. While they required the manufacturer, Bayer, to submit annual reports on the progress of the pediatric studies, it is unclear whether they have submitted such reports. |
| 2008 | Eight batches of MiraLax were tested by the FDA for impurities. According to an FDA spokesperson, this action was in response to the numerous adverse event reports they received, in which patients exhibited “classic symptoms of ethylene glycol ingestion.” In all eight tested batches, the FDA found traces of ethylene glycol (EG) and diethylene glycol (DEG), which are ingredients found in antifreeze. |
| 2011 | The FDA reported that neuropsychiatric events were observed in users of MiraLax, but stated that “no action is necessary at this time based on available information.” |
| 2013 | When the agency conducted further tests of laxatives containing PEG 3350, the amounts of EG and DEG were reportedly so low that they were classified as “acceptable.” |
| 2014 | The FDA agreed to fund a study on MiraLax and other products containing PEG 3350, as requested in the 2012 Citizen Petition. This study would be conducted by the Children’s Hospital of Philadelphia (CHOP), and was to begin some time in 2014. The title of the study is, “The Use of Polyethylene Glycol in the Pediatric Population,” and it is classified as a research project. |
| 2017 | The following information is provided on the status of the CHOP study: (see full text of 11/29/17 email) "CHOP must develop assays for the relevant PEG 3350 metabolites and lower molecular weight polyethylene glycols of interest before it can complete the remaining study activities and analyze the results… Once the assays development is concluded, the testing phase should proceed relatively quickly, as obtaining the required samples should be fairly straightforward… CHOP has indicated that it will be able to complete the remaining study activities and analysis in 2018." |
Current Events
A decade after the safety of MiraLax and other PEG 3350 laxatives was first questioned, the FDA reports that the CHOP study should be completed by the end of 2018.
However, parents are not optimistic about the results of the study based on the eight studies that have already been conducted. These studies are mentioned in the Polyethylene Laxatives Fact sheet from CHOP, and all state that “no behavioral problems were reported.” Although, a key difference between these previous studies and the current CHOP study is that the CHOP study is directly studying behavioral changes in children, while the past studies did not.
As of December 31, 2017, 709 cases of “psychiatric disorders” have been reported to the FDA according to the FDA Adverse Events Reporting System (FAERS) Public Dashboard. Of note, 344 of these reported cases occurred in 2017, most likely due to the increased media attention surrounding the MiraLax safety debate.
While we await the results of the CHOP study on the safety of PEG 3350 products in children, we will continue to monitor the medical and regulatory news for significant developments.
Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
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